(Image via Numinus Wellness Inc.)
As many states move to legalize the use of psilocybin and clinical studies produce promising results, psychedelic therapies are becoming part of mainstream conversation.
For investors eager to secure a promising piece of this market, a business that would stand to benefit the most from its legalization is one that has an ecosystem of solutions centred on the research, development, and delivery of safe, evidence-based, accessible psychedelic-assisted psychotherapies ….
Enter:
Numinus Wellness Inc. (TSX: NUMI, OTCQX: NUMIF, Forum), a mental healthcare company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies.
Recent months have seen major milestones achieved by NUMI’s team, such as its new
BioScience Advisory Board. They will help contribute to advancing Numinus’ IP strategy, including product development and clinical trial activities out of the company's Health Canada-licensed research facility, Numinus Bioscience.
This team joins Numinus’ existing General and Clinical advisory boards, made up of leading industry and subject-matter experts who have been selected to support corporate and therapeutic protocol development. Among them are names that are well documented in the media: Doctors Gabor Maté, Dennis McKenna and Zachary Walsh.
Three key advisors:
Graham Pechenik (JD) – Patent Attorney
After a decade obtaining and defending patents for Fortune 500 companies across the agricultural, chemical, pharmaceutical, biotech, and technology industries, including working on several landmark patent cases both at trial and on appeal, he started
Calyx Law to help cannabis and psychedelics ventures design and implement their IP strategies.
Dr. Paul Spagnuolo (PhD) – Associate Professor, University of Guelph
Specializing and award-winning in the development of nutraceuticals as novel therapeutics using cellular biology, he is a past member of the
Natural Health Products Research Society of Canada and has received funding from the Canadian Institutes of Health Research (CIHR) and the
Natural Sciences and Engineering Research Council of Canada (NSERC).
Dr. Cory Harris (PhD) – Associate Professor, University of Ottawa
Specializing in the ethnobotany, chemistry, and bioactivity of plants, his work involves collaboration with Inuit and First Nations communities, and projects have included investigating the ethical and evidence-based use of alternative medicines and the health benefits and risks of wild plant foods.
Speaking on these appointments, Numinus’ Founder and CEO Payton Nyquvest explained that as Numinus Bioscience continues to demonstrate leadership in developing novel products and processes, opportunities emerge to invite expert advisors to help us discover new areas for collaboration and innovation.
“These appointments reflect our multidisciplinary thinking and intent to focus on natural products as a major component of our IP strategy, in addition to investigating defensible patent opportunities that support both long-term commercial scaling and safe and equitable access for the public.”
Induction to Health Canada's list of licensed psilocybin producers:
The Numinus Bioscience research facility was included on Health Canada's
list of federally licensed psilocybin producers in January, 2022.
Numinus Bioscience is prepared to supply psilocybin in whole mushroom form, through three packaged doses equivalent to 10, 15 and 25mg of psilocybin. These doses are produced under Good Agricultural and Collection Practices and tested for potency and impurities to support patient safety and practitioner confidence. With sufficient clinical data, Numinus may also make available other products that are currently being developed in its IP pipeline, should those meet the standards identified by Health Canada. With its Dealer's License and research facility, Numinus Bioscience is permitted to conduct several activities in addition to the production of psilocybin, including assembly, sale, export, analytical testing and R&D of ketamine, LSD and MDMA.
CEO Nyquvest added that Numinus is glad to see Health Canada committing to broadened mental healthcare access, starting with those in most need.
“As clinical evidence grows, we look forward to making more treatments available and further advancing the development of psychedelic therapies and mental health innovations.”
Health Canada Submission of Phase 1 HOPE Study:
To kick off the year, Numinus announced that it had formally submitted the clinical trial application (CTA) to Health Canada for its
Phase 1 study, HOPE, on a naturally derived Psilocybe extract formulation, NBIO-01. This milestone further progresses and solidifies Numinus' long-standing work on developing safe and effective psychedelic products out of its Health Canada-licensed research facility, Numinus Bioscience.
NBIO-01 is Numinus Bioscience's first proprietary formulation developed from extracts generated using patent-pending technology, for which a patent was earlier submitted to the US Patent and Trade Office in June 2021. The formulation has been developed to stably deliver psilocybin and other synergistic compounds and will be studied for safety and bioavailability.
Numinus’ Science Officer and General Manager, Sharan Sidhu noted that this application significantly advances the company’s product development pipeline, which is aimed at broadening access to safe and effective products for psychedelic-assisted therapies.
“The trial will assess safety and bioavailability and be a stepping stone to the next stage for our IP development. This natural product has been developed to be shelf stable, minimally variable, and consistently meet label claims. The trial will not only assess safety but also give us data on comparative bioavailability.”
Special Access Programme Amended by Health Canada:
Capping off the end of last year, looking ahead to big things to come, the company’s leadership commended Health Canada for amending
the Special Access Programme (SAP) to allow physicians to request patient access to psychedelic treatments, such as MDMA, as well as psilocybin-assisted therapy, for serious treatment-resistant or life-threatening conditions on a case-by-case basis.
Recognizing the growing body of research in psychedelic’s favour, including the pioneering work done by Numinus, Health Canada acknowledges the efficacy of psychedelic-assisted psychotherapy to treat a broad range of mental health conditions that are currently extremely difficult to treat with conventional therapies.
This is important, as such an amendment would have the potential to positively affect the lives of people living serious mental health conditions when other therapies have failed and are otherwise are unsuitable or are unavailable in Canada.
According to Health Canada, access will be provided when there is sufficient data to support the safety and efficacy of the drug for the specific condition of the patient and will be available once the regulations come into force when the amendment is published.
Investors should visit
numinus.com and deepen their due diligence into this company.
There is more information, and a complete corporate presentation posted online.
FULL DISCLOSURE: This is a paid article produced by Stockhouse Publishing.